Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy

Low Tension Glaucoma Clinical Trial

Official title:

Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy in Patients With Normal Tension Glaucoma and Healthy Individuals.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03391518
• Other study ID #: LSFG_WDT
• Status: Active, not recruiting
• Phase: N/A
• First received: December 30, 2017
• Last updated: December 30, 2017
• Start date: February 5, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: December 2017
• Source: Augenabteilung Allgemeines Krankenhaus Linz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study includes Caucasian patients with diagnosis of normal tension glaucoma and age- and sex-matched healthy individuals. Measurements of optic nerve head blood flow will be performed with laser speckle flowgraphy (LSFG). Also, the intraocular pressure (IOP), systolic and diastolic blood pressure, heart rate (HR), mean arterial pressure (MAP) as well as ocular perfusion pressure (OPP) will be evaluated. After baseline measurements individuals will be asked to ingest 800 ml of water in less than five minutes. Measurements will be repeated after 15, 30 and 45 minutes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: January 31, 2018
• Est. primary completion date: December 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• presence of glaucomatous optic disc changes in biomicroscopy and visual field defects or abnormal circumpapillary retinal nerve fibre layer (RNFL) thinning (evaluated by OCT as defined by the on-board software)

• IOP = 21mmHg without therapy

• normal open angle in a gonioscopic examination

• age > 40 years

Exclusion Criteria:

• IOP > 21 mmHg in patients' history

• ametropia > 6 diopters

• cataract with severity greater than grade 2 of the lens opacities classification system (LOCS) classification

• presence of corneal opacities

• uncontrolled hypertension with systolic blood pressure (SBP) > 165mmHg and/or diastolic blood pressure (DBP) > 100mmHg

Related Conditions & MeSH terms

• Glaucoma
• Low Tension Glaucoma

Intervention

Procedure:
• Water drinking test
Ingestion of 800 ml water in less than 5 minutes.

Locations

Country	Name	City	State
Austria	AKh Linz	Linz	Oberösterreich

Sponsors (1)

Lead Sponsor	Collaborator
Augenabteilung Allgemeines Krankenhaus Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ONH blood flow induced by water drinking test	ONH blood flow evaluated by laser speckle flowgraphy	baseline, after 15, 30 and 45 minutes